Abstract
Summary
The global regenerative medicines market is projected to reach USD 49.0 Billion by 2028 from USD 16.0 Billion in 2023, at a CAGR of 25.1% during the forecast period of 2023 to 2028. Factors such as the wide scope in new therapeutic areas and collaborations and partnerships by major market players are predicted to uplift the market in the coming years. Additionally, rise in the focus of personalized medicine and rising regenerative medicine regulatory approvals will provide lucrative market growth. However, lack of long-term data and ethical and legal concerns and high cost of treatments are predicted to restrict the market.
“The cell therapy segment held the dominant share in the regenerative medicine market.”
Based on product, the global regenerative medicine market is segmented into gene therapy, cell therapy (stem cell therapy [cell transplantations, stem cell therapy products {autologous therapy, allogenic therapy] cell-based immunotherapy products), and tissue engineering products. The increasing popularity of stem therapy is expected to drive the expansion of the cell therapy market.
“Musculoskeletal disorders segment accounted for the largest share of the therapeutic area segment in 2022.”
Based on therapeutic area, the regenerative medicine market is segmented into oncology, musculoskeletal disorders, neurology, ophthalmology, dermatology & wound care, cardiovascular diseases, and other applications. This can be attributed to the increasing preavalence of orthopedic disorders and growing interest on musculoskeletal regeneration research.
“APAC region is likely to grow at a faster pace.”
The regenerative medicine market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East and Africa. APAC region is anticipated to grow at a significant CAGR during the forecast period. High burden of chronic diseases, growing per capita income, and the rising demand for new technologies are expected to support regenerative medicine market growth in the region.
The primary interviews conducted for this report can be categorized as follows:
• By Respondent: Supply Side- 80%, and Demand Side - 20%
• By Designation (Supply Side): Managers - 45%, CXOs & Directors - 30%, Executives- 25%
• By Region: North America -55%, Europe -10%, Asia-Pacific -20%, Latin America -10%, MEA- 5%
List of Companies Profiled in the Report:
• Novartis AG (Switzerland)
• Biogen, Inc. (US)
• Sarepta Therapeutics, Inc. (US)
• Gilead Sciences, Inc. (US)
• Amgen Inc. (US)
• Smith+Nephew (UK)
• MEDIPOST Co., Ltd. (Korea)
• JCR Pharmaceuticals Co., Ltd. (Japan)
• Takeda Pharmaceutical Company Limited (Japan)
• CORESTEM, Inc (South Korea)
• Vericel Corporation (US)
• MIMEDX Group, Inc. (US)
• Organogenesis Inc. (US)
• Medtronic (Ireland)
• Bristol-Myers Squibb Company (US)
• Orthocell Ltd. (Australia)
• Mesoblast Ltd. (Australia)
• BioRestorative Therapies, Inc. (US)
• Pluristem Therapeutics Inc. (US)
• TEGOSCIENCE (South Korea)
• ANTEROGEN.CO.,LTD. (South Korea)
• Bluebird bio, Inc. (US)
• Stempeutics Research Pvt Ltd. (India)
• Sibiono GeneTech Co. Ltd. (China)
• Aspect Biosystems Ltd. (Canada)
• Athersys, Inc. (US)
Research Coverage:
This report provides a detailed picture of the regenerative medicine market. It aims to estimate the size and future growth potential of the market across different segments, such as product, therapeutic area and region. The report also includes an in-depth competitive analysis of the key market players, along with their company profiles, recent developments, and key market strategies.
Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall regenerative medicine market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their business and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
• Analysis of key drivers (Growing focus on personalized medicine, steep rise of regulatory approvals in regenerative medicine, rising collaborations and partnerships by major market players, increasing scope in new therapeutic areas), restraints (Lack of long-term data, Ethical and legal concerns and high cost of treatments), opportunities (Integration with artificial intelligence and big data, Harnessing the potential of 3D printing, Growing number of organ transplants) and challenges (Lack of favorable reimbursement policies across various regions) are influencing the growth of regenerative medicine market.
• Product Development/Innovation: Detailed insights on newly launched products of the regenerative medicine market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the regenerative medicine market across varied regions.
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the regenerative medicine market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players include Novartis AG (Switzerland), Biogen, Inc. (US), Sarepta Therapeutics, Inc. (US), Gilead Sciences, Inc. (US), Amgen Inc. (US), Smith+Nephew (UK), MEDIPOST Co., Ltd. (Korea), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan) and CORESTEM, Inc (South Korea) and among others in the regenerative medicine market.
Table of Contents
1 INTRODUCTION 35
1.1 STUDY OBJECTIVES 35
1.2 MARKET DEFINITION 35
1.2.1 INCLUSIONS & EXCLUSIONS 36
1.3 MARKET SCOPE 36
1.3.1 MARKETS COVERED 36
1.3.2 YEARS CONSIDERED 37
1.3.3 CURRENCY CONSIDERED 37
1.4 RESEARCH LIMITATIONS 37
1.5 STAKEHOLDERS 38
1.6 SUMMARY OF CHANGES 38
1.7 IMPACT OF RECESSION ON REGENERATIVE MEDICINE MARKET 39
2 RESEARCH METHODOLOGY 40
2.1 RESEARCH DATA 40
2.1.1 SECONDARY DATA 41
2.1.2 PRIMARY DATA 42
2.2 MARKET SIZE ESTIMATION 43
2.2.1 PRIMARY INSIGHTS 47
2.2.2 SEGMENT ASSESSMENT METHODOLOGY: REGENERATIVE MEDICINE MARKET 47
2.3 MARKET BREAKDOWN & DATA TRIANGULATION 50
2.4 STUDY ASSUMPTIONS 51
2.5 RISK ANALYSIS 51
2.6 IMPACT OF RECESSION ON REGENERATIVE MEDICINE MARKET 52
3 EXECUTIVE SUMMARY 54
4 PREMIUM INSIGHTS 57
4.1 REGENERATIVE MEDICINE MARKET OVERVIEW 57
4.2 NORTH AMERICA: REGENERATIVE MEDICINE MARKET 58
4.3 REGENERATIVE MEDICINE MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 59
5 MARKET OVERVIEW 60
5.1 INTRODUCTION 60
5.2 MARKET DYNAMICS 60
5.2.1 DRIVERS 61
- 5.2.1.1 Growing focus on personalized medicine 61
- 5.2.1.2 Emerging applications in new therapeutic areas 62
- 5.2.1.3 Increasing collaborations and partnerships by major market players 64
- 5.2.1.4 Increasing regulatory approvals in regenerative medicine 65
5.2.2 RESTRAINTS 66
- 5.2.2.1 Lack of long-term data 66
- 5.2.2.2 Ethical and legal concerns and high cost of treatments 66
5.2.3 OPPORTUNITIES 67
- 5.2.3.1 Harnessing the potential of 3D printing 67
- 5.2.3.2 Integration with artificial intelligence and big data 68
- 5.2.3.3 Growing number of organ transplants 68
5.2.4 CHALLENGES 69
- 5.2.4.1 Lack of favorable reimbursement policies across various regions 69
5.3 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 70
5.4 PRICING ANALYSIS 71
5.4.1 AVERAGE SELLING PRICE TREND OF KEY PLAYERS, BY PRODUCT 71
5.5 SUPPLY CHAIN ANALYSIS 72
5.6 VALUE CHAIN ANALYSIS 73
5.7 ECOSYSTEM ANALYSIS 74
5.8 TECHNOLOGY ANALYSIS 76
5.9 PATENT ANALYSIS 78
5.10 KEY CONFERENCES & EVENTS IN 2024-2025 81
5.10.1 REGENERATIVE MEDICINE CONFERENCES IN 2024-2025 81
5.11 TARIFF & REGULATORY LANDSCAPE 82
5.11.1 FDA APPROVALS 82
5.11.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 83
5.12 PORTER’S FIVE FORCES ANALYSIS 87
5.12.1 THREAT OF NEW ENTRANTS 87
5.12.2 THREAT OF SUBSTITUTES 87
5.12.3 BARGAINING POWER OF BUYERS 88
5.12.4 BARGAINING POWER OF SUPPLIERS 88
5.12.5 DEGREE OF COMPETITION 88
5.13 KEY STAKEHOLDERS & BUYING CRITERIA 89
5.13.1 KEY STAKEHOLDERS IN BUYING PROCESS 89
5.13.2 BUYING CRITERIA FOR REGENERATIVE MEDICINE PRODUCTS 89
5.14 PIPELINE ANALYSIS 90
6 REGENERATIVE MEDICINE MARKET, BY PRODUCT 94
6.1 INTRODUCTION 95
6.2 CELL THERAPY 95
6.2.1 STEM CELL THERAPY 98
- 6.2.1.1 Cell transplantations 101
- 6.2.1.1.1 Potential of Allo-SCT in treating AML to drive segmental growth 101
- 6.2.1.2 Stem cell therapy products 104
- 6.2.1.2.1 Autologous therapy 107
- 6.2.1.2.1.1 Low risk of post-treatment complications to support segment growth 107
- 6.2.1.2.2 Allogeneic therapy 110
- 6.2.1.2.2.1 High potential in disease treatment to ensure demand and development 110
- 6.2.1.2.1 Autologous therapy 107
- 6.2.1.1 Cell transplantations 101
6.2.2 CELL-BASED IMMUNOTHERAPY 113
- 6.2.2.1 Growing adoption of T-cell therapy in cancer treatment to support market growth 113
6.3 GENE THERAPY 116
6.3.1 STRONG PRODUCT PIPELINE DUE TO BROADENING APPLICATIONS IN DISEASE TREATMENT TO DRIVE MARKET 116
6.4 TISSUE ENGINEERING 119
6.4.1 HIGH DEMAND FOR TISSUE ENGINEERING PRODUCTS IN DERMATOLOGY & WOUND CARE APPLICATIONS TO DRIVE MARKET 119
7 REGENERATIVE MEDICINE MARKET, BY THERAPEUTIC AREA 123
7.1 INTRODUCTION 124
7.2 ONCOLOGY 125
7.2.1 INCREASING STEM CELL TRANSPLANTS TO DRIVE MARKET 125
7.3 MUSCULOSKELETAL DISORDERS 130
7.3.1 RISING RESEARCH ON MUSCULOSKELETAL REGENERATION AND PREVALENCE OF ORTHOPEDIC DISORDERS TO DRIVE MARKET 130
7.4 DERMATOLOGY & WOUND CARE 133
7.4.1 RISING USE OF WOUND CARE BIOLOGICS TO DRIVE MARKET 133
7.5 CARDIOVASCULAR DISEASES 136
7.5.1 INCREASING USE OF MSCS FOR CLINICAL RESEARCH ON IHD TO SUPPORT MARKET GROWTH 136
7.6 OPHTHALMOLOGY 139
7.6.1 REGENERATION OF EYE TISSUES FOR AMD TO SUPPORT MARKET GROWTH 139
7.7 NEUROLOGY 143
7.7.1 GROWING NUMBER OF GENE THERAPY PRODUCTS APPROVED FOR NEUROLOGICAL DISEASE TREATMENT TO DRIVE MARKET GROWTH 143
7.8 OTHER THERAPEUTIC AREAS 146
8 REGENERATIVE MEDICINE MARKET, BY REGION 150
8.1 INTRODUCTION 151
8.2 NORTH AMERICA 152
8.2.1 US 156
- 8.2.1.1 Rising number of pipeline products for regenerative medicine to drive market 156
8.2.2 CANADA 159
- 8.2.2.1 Rising government initiatives for regenerative medicine research to drive market 159
8.2.3 NORTH AMERICA: RECESSION IMPACT 162
8.3 EUROPE 163
8.3.1 GERMANY 166
- 8.3.1.1 Rising focus on clinical research and patent approvals to drive market 166
8.3.2 UK 168
- 8.3.2.1 Incorporating regenerative medicine into commercial healthcare services under NHS to drive market 168
8.3.3 FRANCE 171
- 8.3.3.1 Structured regulatory framework to drive regenerative medicine product pipeline 171
8.3.4 ITALY 173
- 8.3.4.1 Rising prevalence of neurological and cardiovascular disorders to drive market 173
8.3.5 SPAIN 176
- 8.3.5.1 Favorable regulatory environment to drive product pipeline 176
8.3.6 REST OF EUROPE 179
8.3.7 EUROPE: RECESSION IMPACT 182
8.4 ASIA PACIFIC 182
8.4.1 CHINA 186
- 8.4.1.1 Favorable government support for development of regenerative medicine to drive market 186
8.4.2 JAPAN 189
- 8.4.2.1 Regulatory amendments to pharmaceutical legislation to drive commercialization of therapies 189
8.4.3 INDIA 192
- 8.4.3.1 Introduction of novel therapies for CVD and cancer to support market growth 192
8.4.4 SOUTH KOREA 194
- 8.4.4.1 Strong research base and availability of funds to support market growth 194
8.4.5 AUSTRALIA 197
- 8.4.5.1 Increasing incidence of sports injuries to support market growth 197
8.4.6 REST OF ASIA PACIFIC 199
8.4.7 ASIA PACIFIC: RECESSION IMPACT 201
8.5 LATIN AMERICA 202
8.5.1 BRAZIL 204
- 8.5.1.1 Gradual increase in pharmaceutical R&D to support market growth 204
8.5.2 REST OF LATIN AMERICA 206
8.5.3 LATIN AMERICA: RECESSION IMPACT 209
8.6 MIDDLE EAST 210
8.6.1 GROWING FOCUS ON GENETIC MEDICINE DEVELOPMENT PROJECTS TO DRIVE MARKET GROWTH IN COMING YEARS 210
8.6.2 MIDDLE EAST: RECESSION IMPACT 212
8.7 AFRICA 213
8.7.1 GROWING COLLABORATIONS TO SUPPORT GROWTH IN COMING YEARS 213
8.7.2 AFRICA: RECESSION IMPACT 215
9 COMPETITIVE LANDSCAPE 216
9.1 INTRODUCTION 216
9.2 RIGHT-TO-WIN APPROACHES ADOPTED BY KEY PLAYERS 216
9.3 REVENUE SHARE ANALYSIS 219
9.4 MARKET SHARE ANALYSIS 219
9.5 COMPANY EVALUATION MATRIX 221
9.5.1 STARS 222
9.5.2 EMERGING LEADERS 222
9.5.3 PERVASIVE PLAYERS 222
9.5.4 PARTICIPANTS 222
9.5.5 COMPANY FOOTPRINT ANALYSIS 224
9.6 START-UP/SME EVALUATION MATRIX 226
9.6.1 PROGRESSIVE COMPANIES 226
9.6.2 RESPONSIVE COMPANIES 226
9.6.3 DYNAMIC COMPANIES 226
9.6.4 STARTING BLOCKS 226
9.6.5 COMPETITIVE BENCHMARKING 228
9.7 COMPETITIVE SCENARIO & TRENDS 230
9.7.1 PRODUCT LAUNCHES 230
9.7.2 DEALS 233
9.7.3 OTHER DEVELOPMENTS 237
10 COMPANY PROFILES 239
10.1 KEY MARKET PLAYERS 239
10.1.1 NOVARTIS AG 239
10.1.2 BIOGEN INC 244
10.1.3 GILEAD SCIENCES, INC 248
10.1.4 SAREPTA THERAPEUTICS, INC 253
10.1.5 AMGEN, INC 256
10.1.6 SMITH+NEPHEW 259
10.1.7 MEDIPOST CO., LTD 262
10.1.8 JCR PHARMACEUTICALS CO., LTD 265
10.1.9 TAKEDA PHARMACEUTICAL COMPANY LIMITED 267
10.1.10 CORESTEM, INC 270
10.1.11 VERICEL CORPORATION 272
10.1.12 MIMEDX GROUP, INC 274
10.1.13 ORGANOGENESIS INC 278
10.1.14 MEDTRONIC 281
10.1.15 BRISTOL-MYERS SQUIBB COMPANY 284
10.2 OTHER PLAYERS 288
10.2.1 ORTHOCELL LTD 288
10.2.2 MESOBLAST LTD 289
10.2.3 BIORESTORATIVE THERAPIES, INC 290
10.2.4 PLURISTEM THERAPEUTICS INC 290
10.2.5 TEGOSCIENCE 291
10.2.6 ANTEROGEN.CO.,LTD 292
10.2.7 BLUEBIRD BIO, INC 293
10.2.8 STEMPEUTICS RESEARCH PVT. LTD 294
10.2.9 SIBIONO GENETECH CO. LTD 294
10.2.10 ASPECT BIOSYSTEMS 295
11 APPENDIX 297
11.1 DISCUSSION GUIDE 297
11.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 300
11.3 CUSTOMIZATION OPTIONS 302
11.4 RELATED REPORTS 302
11.5 AUTHOR DETAILS 303